{"id":6666,"date":"2024-06-10T15:58:00","date_gmt":"2024-06-10T15:58:00","guid":{"rendered":"https:\/\/www.waters.com\/blog\/?p=6666"},"modified":"2026-01-20T13:46:47","modified_gmt":"2026-01-20T13:46:47","slug":"complete-guide-to-particle-size-distribution-and-analysis","status":"publish","type":"post","link":"https:\/\/www.waters.com\/blog\/complete-guide-to-particle-size-distribution-and-analysis\/","title":{"rendered":"Complete Guide to Particle Size Distribution and Analysis"},"content":{"rendered":"\n<p>Understanding your product\u2019s particle size distribution can help you predict its manufacturability, efficacy, quality, bioavailability, and shelf life.\u202fLarger particles can decrease porosity,\u00a0limiting\u00a0the passage of the drug and potentially blocking it from reaching its target site.\u202f Conversely,\u00a0very small\u00a0particles can add to the surface area of a drug, which can lead to unintended side effects. In short, the wrong particle sizes can interfere with production, yields, and profits.\u00a0<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" width=\"903\" height=\"903\" src=\"https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-10.png\" alt=\"Three scientists in the lab working on particle size distribution\" class=\"wp-image-6667\" srcset=\"https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-10.png 903w, https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-10-300x300.png 300w, https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-10-150x150.png 150w, https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-10-768x768.png 768w, https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-10-650x650.png 650w, https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-10-350x350.png 350w\" sizes=\"(max-width: 903px) 100vw, 903px\" \/><\/figure>\n<\/div>\n\n\n<p>Nearly all\u00a0biotherapeutics\u00a0contain<strong>\u00a0subvisible particles <\/strong>(between 2 and 100 \u00b5m in\u00a0diameter), varying in volume and shape. The most important property of particulate samples is particle size, which can be crucial to the success of your final product.\u202f\u00a0<\/p>\n\n\n\n<p>Particle size distribution analysis is a statistical diagram of particles of&nbsp;different sizes. It measures the number and variation of particle size in a drug. This distribution is usually displayed as a frequency distribution curve.\u202f&nbsp;<\/p>\n\n\n\n<p>Most particle diameter analysis forms a bell curve\u2014in this case, the x-axis&nbsp;represents&nbsp;the particle size, and the y-axis&nbsp;represents&nbsp;the frequency of a given-sized particle. Usually, a range of statistical parameters is calculated. These parameters can include:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mean<\/strong>\u2014The average size of a population\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Median<\/strong>\u2014The middle size, in which half the population is below and the other half above that size\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mode<\/strong>\u2014The size that occurs the most\u00a0<\/li>\n<\/ul>\n\n\n\n<p>Each bell curve will\u00a0probably be\u00a0shaped differently, and that shape helps characterize the particles in your product. The placement of mean, median, and mode helps\u00a0determine\u00a0that shape. Pharmaceutical manufacturers also use D-values to calculate a size distribution curve:<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" width=\"903\" height=\"768\" src=\"https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-11.png\" alt=\"Graph of particle counts by diameter (ECD)\" class=\"wp-image-6670\" srcset=\"https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-11.png 903w, https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-11-300x255.png 300w, https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-11-768x653.png 768w\" sizes=\"(max-width: 903px) 100vw, 903px\" \/><figcaption class=\"wp-element-caption\">D50\u2014median particle size; D10\u201410 percent of particles are smaller than this number; <br>D90\u201490 percent of particles are smaller than this number\u00a0<\/figcaption><\/figure>\n<\/div>\n\n\n<p>Narrower distribution curves will have these three D-values grouped more closely. A tight distribution curve is\u00a0optimal\u00a0because, under that curve, particle sizes are more alike.\u202f\u00a0<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-6666_3fbffc-b0 .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-6666_3fbffc-b0 .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-6666_3fbffc-b0\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n<style>.wp-block-kadence-advancedheading.kt-adv-heading6666_86bd5c-00, .wp-block-kadence-advancedheading.kt-adv-heading6666_86bd5c-00[data-kb-block=\"kb-adv-heading6666_86bd5c-00\"]{font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading6666_86bd5c-00 mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading6666_86bd5c-00[data-kb-block=\"kb-adv-heading6666_86bd5c-00\"] mark.kt-highlight{font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading6666_86bd5c-00 img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading6666_86bd5c-00[data-kb-block=\"kb-adv-heading6666_86bd5c-00\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style>\n<h2 class=\"kt-adv-heading6666_86bd5c-00 wp-block-kadence-advancedheading\" data-kb-block=\"kb-adv-heading6666_86bd5c-00\">Techniques for particle size analysis<\/h2>\n\n\n\n<p>There are several particle size analytical methods available. The proper technique will depend on the types of particles&nbsp;analyzed&nbsp;and their size. Methods include:&nbsp;<\/p>\n\n\n\n<p><strong>Sieving<\/strong>: One of the oldest methods of sorting particles by size. Test sieves consist of a woven-wire mesh that creates pores of the desired size. Mechanical sieving works best when\u00a0the majority of\u00a0particles are larger than 75\u00a0\u00b5m, and\u00a0is most useful for coarser grades of powder or granule.\u202f\u00a0<\/p>\n\n\n\n<p><strong>Sedimentation<\/strong>: This measures the time taken for particles to travel through a viscous liquid. Smaller particles take longer to travel than larger ones, and this technique is useful for sizes below 10 \u00b5m. This technique cannot measure sub-micrometer\u00a0particles.\u202f\u00a0<\/p>\n\n\n\n<p><strong>Laser diffraction<\/strong>: Also known as static laser light scattering, this method measures size indirectly by detecting intensity distributions of laser light scattered by particles. Shape evaluation is not possible (it assumes all particles are spherical), and low resolution and sensitivity are disadvantages. It is not as effective in polydisperse samples.\u202f\u00a0<\/p>\n\n\n\n<p><strong>Dynamic light scattering (DLS)<\/strong>: In this method, particles move past a camera and are\u00a0analyzed\u00a0in real time. Millions of particles can be examined in minutes with this method. DLS can report a variety of size as well as shape parameters. Currently, DLS is the\u00a0most commonly used\u00a0method for biotherapeutic particle size distribution analysis.\u202f\u00a0<\/p>\n\n\n\n<p><strong>Imaging (microscopy, SEM)<\/strong>: Here, particles are measured by comparing their size against a grid of lines and counting them. However, millions of particles need to be measured to achieve a statistically valid analysis. Automated analysis of electron micrographs helps ease this barrier. This method is useful for particle sizes within 0.2 to 100 \u00b5m.\u00a0<\/p>\n\n\n\n<p><strong>BMI\/FMM<\/strong>: <a href=\"https:\/\/www.waters.com\/nextgen\/global\/applications\/biopharma-and-pharma\/protein-therapies\/particle-counting-and-identification.html\" target=\"_blank\" rel=\"noreferrer noopener\">Backgrounded membrane imaging<\/a>\u202f(BMI), combined with fluorescence membrane microscopy, are the basis of\u00a0the\u00a0<a href=\"https:\/\/www.waters.com\/nextgen\/global\/products\/particle-analyzers.html\">Aura\u00a0Particle\u00a0Analysis\u00a0System.<\/a> BMI, a high-contrast imaging technique, develops clear pictures of particles in a sample. It only requires 5 \u00b5l of sample and can deliver results in a minute.\u202f Fluorescence Membrane Imaging (FMM) labels particles using specific fluorescent dyes or immunoassays, resulting in simple and definitive identification.\u00a0<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-6666_9e1469-65 .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-6666_9e1469-65 .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-6666_9e1469-65\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n<style>.wp-block-kadence-advancedheading.kt-adv-heading6666_23b4a3-fc, .wp-block-kadence-advancedheading.kt-adv-heading6666_23b4a3-fc[data-kb-block=\"kb-adv-heading6666_23b4a3-fc\"]{font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading6666_23b4a3-fc mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading6666_23b4a3-fc[data-kb-block=\"kb-adv-heading6666_23b4a3-fc\"] mark.kt-highlight{font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading6666_23b4a3-fc img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading6666_23b4a3-fc[data-kb-block=\"kb-adv-heading6666_23b4a3-fc\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style>\n<h2 class=\"kt-adv-heading6666_23b4a3-fc wp-block-kadence-advancedheading\" data-kb-block=\"kb-adv-heading6666_23b4a3-fc\">Equipment for particle size measurement\u00a0<\/h2>\n\n\n\n<p><a href=\"https:\/\/www.waters.com\/nextgen\/global\/products\/particle-analyzers.html\" target=\"_blank\" rel=\"noreferrer noopener\">Particle size measurement equipment<\/a>\u202fcan vary in complexity, from a simple mesh sieve and sedimentation to more automated scanning electron microscopy and Aura\u2019s BMI\/FMM\u00a0analysis\u00a0technology. Particle size\u00a0analyzers\u00a0using optics or laser diffraction can provide information on a wide range of particle sizes, while the Aura\u00a0System can\u00a0determine\u00a0the number and type of particles in your sample. Other methods, such as Coulter counters, measure temporary changes in liquid conductivity.\u202f<\/p>\n\n\n\n<p>Measurement accuracy will vary among these techniques and instruments. In general, the more sophisticated the technology and automated the process, the more accurate measurements will be generated. If looking at larger, homogeneous particles, a sieve or sediment analysis may be all that\u2019s necessary. However, most biotherapeutic formulations have complex particle size distributions that need more sophisticated methods to arrive at actionable results.\u202f&nbsp;<\/p>\n\n\n\n<p>Choosing the right particle size distribution analysis equipment is largely dependent on what particle size you want to measure, accurately. FDA and USP &lt;788&gt; demand a virtual elimination of subvisible particles (below 100 \u00b5m), so most biotherapeutic\/pharmaceutical analyses will need to include that size range. Dynamic image analysis can detect down to 0.8 \u00b5m, while laser diffraction can detect particles down to 10 nm, and dynamic light scattering down to 0.3 nm; due to particle size limitations of these methods, they are not well suited for subvisible and visible particle analysis.&nbsp;The&nbsp;Aura&nbsp;System can detect visible and subvisible particles, down to 1 \u00b5m.\u202f&nbsp;<\/p>\n\n\n\n<p>For pharmaceutical manufacturing, arriving at the correct particle size distribution via the right analysis ensures product consistency and quality. An incorrect particle size distribution may prevent the active pharmaceutical ingredient from reaching the right part of the body at the right concentration. Particles that are too large can impact inhaled drugs, too\u2014if too large, they remain stuck in the throat. If too small, the patient will probably exhale them before they can reach the right part of the lungs. Smaller particle sizes can also eliminate the need to eat food while taking an oral drug. Smaller particles are less likely to irritate the gastrointestinal tract.\u202f&nbsp;<\/p>\n\n\n\n<p>Particle size distribution is also important for determining how well a drug is manufactured. Small particles often impede flow (how particles move with each other and in connection with their container). Size also dictates how well a tablet holds together, which determines the shelf life of a product.\u202f&nbsp;<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-6666_ef1ae2-0e .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-6666_ef1ae2-0e .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-6666_ef1ae2-0e\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n<style>.wp-block-kadence-advancedheading.kt-adv-heading6666_6cc10b-00, .wp-block-kadence-advancedheading.kt-adv-heading6666_6cc10b-00[data-kb-block=\"kb-adv-heading6666_6cc10b-00\"]{font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading6666_6cc10b-00 mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading6666_6cc10b-00[data-kb-block=\"kb-adv-heading6666_6cc10b-00\"] mark.kt-highlight{font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading6666_6cc10b-00 img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading6666_6cc10b-00[data-kb-block=\"kb-adv-heading6666_6cc10b-00\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style>\n<h2 class=\"kt-adv-heading6666_6cc10b-00 wp-block-kadence-advancedheading\" data-kb-block=\"kb-adv-heading6666_6cc10b-00\">Software and standards for particle size distribution\u00a0<\/h2>\n\n\n\n<p>Having the right particle size analysis software is key to making research simpler,\u00a0faster\u00a0and more efficient. Tools like\u202f<a href=\"https:\/\/www.waters.com\/nextgen\/global\/products\/informatics-and-software\/particle-vue-software.html\" target=\"_blank\" rel=\"noreferrer noopener\">Particle Vue Automated Particle Analysis Software<\/a>\u202fcombine analytics and algorithms with multidimensional visualization, detecting and\u00a0analyzing\u00a0particles in a variety of samples. With advanced algorithms, particle size\u00a0analytics\u00a0and image navigation, you can see images and data in one simple view. It will also let you dive deeper into your sample analysis with advanced data management and visualizations. A good software package will let you\u00a0analyze\u00a0subpopulations of particles, helping make smarter decisions.\u202f\u00a0<\/p>\n\n\n\n<p>International standards and regulations for particle size distribution are set by the US Pharmacopeia (USP), particularly USP &lt;788&gt;, and the US Food and Drug Administration (FDA). USP standards for injectable therapies maintain that the average number of particles in tested samples does not exceed 12 per ml equal to or greater than 10 \u00b5m and does not exceed 2 per mL equal to or greater than 25 \u00b5m.&nbsp;<\/p>\n\n\n\n<p>According to the US FDA, particle size distribution should be measured at release (at least). Most particles should be under 5 \u00b5m, \u201conly a minimum number should be over 10 \u00b5m,\u201d FDA guidance states. Previously, FDA guidelines had been ambiguous, but no longer. Recent FDA warning letters to pharmaceutical firms have advised that certain product containers, at least, be free of particles.&nbsp;<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" width=\"903\" height=\"699\" src=\"https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-12.png\" alt=\"Graph depicting FL-1 intensity (455 mm) by diameter (ECD).\" class=\"wp-image-6671\" srcset=\"https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-12.png 903w, https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-12-300x232.png 300w, https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-12-768x594.png 768w\" sizes=\"(max-width: 903px) 100vw, 903px\" \/><\/figure>\n<\/div>\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-6666_a9543e-bb .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-6666_a9543e-bb .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-6666_a9543e-bb\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n<style>.wp-block-kadence-advancedheading.kt-adv-heading6666_c25315-48, .wp-block-kadence-advancedheading.kt-adv-heading6666_c25315-48[data-kb-block=\"kb-adv-heading6666_c25315-48\"]{font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading6666_c25315-48 mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading6666_c25315-48[data-kb-block=\"kb-adv-heading6666_c25315-48\"] mark.kt-highlight{font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading6666_c25315-48 img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading6666_c25315-48[data-kb-block=\"kb-adv-heading6666_c25315-48\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style>\n<h2 class=\"kt-adv-heading6666_c25315-48 wp-block-kadence-advancedheading\" data-kb-block=\"kb-adv-heading6666_c25315-48\">Particle size distribution analysis challenges and solutions\u00a0<\/h2>\n\n\n\n<p>Challenges to particle size distribution analysis lie in two main areas: <strong>regulatory\/USP requirements <\/strong>and the <strong>complex nature of biotherapeutic formulations<\/strong>. However, it is important to produce a drug that can be sold at a premium, have minimal rejection rates or lot losses, and show compliance with regulations and standards.\u202f\u00a0<\/p>\n\n\n\n<p>Higher resolution is key to compliance since the FDA and USP &lt;788&gt; require virtual elimination of subvisible particles in a sample. This means that instruments and analysis must be able to both detect and measure particles down to at least 5 \u00b5m. Not all techniques can achieve this. Shape of a particle is also important to characterize, since assuming all particles are spherical (or at least the same shape) introduces the probability of increased error and decreased accuracy. Determining particle shape is only possible by introducing microscopy- or light-diffusion methods.\u202f&nbsp;<\/p>\n\n\n\n<p>The\u00a0measuring and analysis tools\u00a0in the <a href=\"https:\/\/www.waters.com\/nextgen\/global\/products\/particle-analyzers.html\">Aura System<\/a>\u00a0can uncover subvisible particle data, leading to more\u00a0accurate\u00a0results, better decision-making and improved regulatory\/standardization compliance.\u00a0BMI\u00a0provides clearer images of particles than ever\u00a0before, and\u00a0provides that data quickly.\u00a0\u00a0FMM\u00a0uses specific dyes or fluorescently\u00a0labeled\u00a0antibodies to\u00a0identify\u00a0specific aggregates. In addition, Side Illumination Membrane Imaging (SIMI), a part of every BMI measurement, characterizes extrinsic or inorganic particles in your sample. Moreover, quality control and assurance\u00a0are\u00a0improved because you can conduct these tests with\u00a0very little\u00a0sample (5 \u00b5l) and start testing much earlier in the discovery and development stages of your proposed biotherapeutic.\u202f\u00a0<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-6666_ed4ccb-2b .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-6666_ed4ccb-2b .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-6666_ed4ccb-2b\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n<style>.wp-block-kadence-advancedheading.kt-adv-heading6666_de6f9f-21, .wp-block-kadence-advancedheading.kt-adv-heading6666_de6f9f-21[data-kb-block=\"kb-adv-heading6666_de6f9f-21\"]{font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading6666_de6f9f-21 mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading6666_de6f9f-21[data-kb-block=\"kb-adv-heading6666_de6f9f-21\"] mark.kt-highlight{font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading6666_de6f9f-21 img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading6666_de6f9f-21[data-kb-block=\"kb-adv-heading6666_de6f9f-21\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style>\n<h2 class=\"kt-adv-heading6666_de6f9f-21 wp-block-kadence-advancedheading\" data-kb-block=\"kb-adv-heading6666_de6f9f-21\">Future trends and innovations in particle size distribution<\/h2>\n\n\n\n<p>The move toward complex biotherapeutics\u2014cell therapy, gene therapy, therapeutic proteins, and vaccines\u2014is accelerating. These new drugs are often more efficacious and targeted, with the potential to treat diseases that previously had no cure, with fewer side effects.\u202f&nbsp;<\/p>\n\n\n\n<p>This promise can only be upheld with superior product quality. Particle size analysis plays an enormous role in this promise, by reducing the health and quality risks posed by too many particles, and particles of the wrong size. Innovations in imaging and particle detection and counting, such as the&nbsp;Aura&nbsp;Systems&nbsp;family, will improve resolution, making products better and detecting particle issues at earlier stages of development. New innovations like machine learning will also improve analytical tools and software, allowing for better, more precise decisions, faster.\u202f&nbsp;<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-6666_c8786e-19 .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-6666_c8786e-19 .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-6666_c8786e-19\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n<style>.wp-block-kadence-advancedheading.kt-adv-heading6666_d0ec84-d3, .wp-block-kadence-advancedheading.kt-adv-heading6666_d0ec84-d3[data-kb-block=\"kb-adv-heading6666_d0ec84-d3\"]{font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading6666_d0ec84-d3 mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading6666_d0ec84-d3[data-kb-block=\"kb-adv-heading6666_d0ec84-d3\"] mark.kt-highlight{font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading6666_d0ec84-d3 img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading6666_d0ec84-d3[data-kb-block=\"kb-adv-heading6666_d0ec84-d3\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style>\n<h2 class=\"kt-adv-heading6666_d0ec84-d3 wp-block-kadence-advancedheading\" data-kb-block=\"kb-adv-heading6666_d0ec84-d3\">More accurate particle size distribution analysis is key to quality and safety\u00a0<\/h2>\n\n\n\n<p>Particle size distribution has become an important measure of biotherapeutic product quality and safety, as more manufacturers move toward the adoption of cell, gene, and protein drugs and vaccines. Since particles are much more prevalent in these formulations, regulators and manufacturers alike have looked toward more accurate analysis as the key to approving and creating these therapies. Particle size distribution:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Take statistical measurements (mean, median and mode) to determine the makeup of a sample. These distributions make up the USP and FDA standards and regulations on approving a new product.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Many technologies can produce particle size distribution curves, but relatively few can accurately detect subvisible particles which present the highest risks to product quality and rejection.\u00a0<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Newer methods\u00a0using\u00a0Aura\u00a0Systems\u00a0can image and characterize smaller particles, providing a more complete picture of particle distribution in your samples.\u202f\u00a0<\/li>\n<\/ul>\n\n\n\n<p>If you would like to continue the conversation on particle size distribution and the Aura\u00a0Systems\u00a0family,\u202f<a href=\"https:\/\/www.waters.com\/nextgen\/global\/contact-waters.html\" target=\"_blank\" rel=\"noreferrer noopener\">please contact us.<\/a>\u00a0<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-6666_e737f2-dd .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-6666_e737f2-dd .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-6666_e737f2-dd\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n<style>.wp-block-kadence-advancedheading.kt-adv-heading6666_3e43e5-69, .wp-block-kadence-advancedheading.kt-adv-heading6666_3e43e5-69[data-kb-block=\"kb-adv-heading6666_3e43e5-69\"]{font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading6666_3e43e5-69 mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading6666_3e43e5-69[data-kb-block=\"kb-adv-heading6666_3e43e5-69\"] mark.kt-highlight{font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading6666_3e43e5-69 img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading6666_3e43e5-69[data-kb-block=\"kb-adv-heading6666_3e43e5-69\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style>\n<h2 class=\"kt-adv-heading6666_3e43e5-69 wp-block-kadence-advancedheading\" data-kb-block=\"kb-adv-heading6666_3e43e5-69\">References<\/h2>\n\n\n\n<p><a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0168365919301130\">https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0168365919301130<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Understanding your product\u2019s particle size distribution can help you predict its manufacturability, efficacy, quality, bioavailability, and shelf life.\u202fLarger particles can decrease porosity,\u00a0limiting\u00a0the passage of the drug and potentially blocking it from reaching its target site.\u202f Conversely,\u00a0very small\u00a0particles can add to the surface area of a drug, which can lead to unintended side effects. In short,&#8230;<\/p>\n","protected":false},"author":60,"featured_media":6667,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_seopress_robots_primary_cat":"none","_seopress_titles_title":"%%post_title%% %%sep%% %%sitetitle%%","_seopress_titles_desc":"Learn all about today's available methods for particle size analysis, including sieving, BMI\/FMM, and imaging, plus challenges and how to overcome.","_seopress_robots_index":"","_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"categories":[228,1],"tags":[51,52,722],"class_list":["post-6666","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biopharmaceutical","category-general","tag-biopharma","tag-biopharmaceutical","tag-particle-analysis"],"acf":[],"taxonomy_info":{"category":[{"value":228,"label":"Biopharmaceutical"},{"value":1,"label":"General"}],"post_tag":[{"value":51,"label":"biopharma"},{"value":52,"label":"biopharmaceutical"},{"value":722,"label":"particle analysis"}]},"featured_image_src_large":["https:\/\/www.waters.com\/blog\/wp-content\/uploads\/image-10.png",903,903,false],"author_info":{"display_name":"Waters Staff","author_link":"https:\/\/www.waters.com\/blog\/author\/dmason\/"},"comment_info":"","category_info":[{"term_id":228,"name":"Biopharmaceutical","slug":"biopharmaceutical","term_group":0,"term_taxonomy_id":228,"taxonomy":"category","description":"We help ensure the medicines people take every day are reliably safe and effective, from the common aspirin to the most complex biotherapy. 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Tests performed using our liquid chromatography-mass spectrometry (LC-MS) instruments ensure the efficacy and safety of these complex, protein-based drugs well before they reach the patient.","cat_name":"Biopharmaceutical","category_nicename":"biopharmaceutical","category_parent":25},{"term_id":1,"name":"General","slug":"general","term_group":0,"term_taxonomy_id":1,"taxonomy":"category","description":"","parent":0,"count":52,"filter":"raw","term_order":"0","cat_ID":1,"category_count":52,"category_description":"","cat_name":"General","category_nicename":"general","category_parent":0}],"tag_info":[{"term_id":51,"name":"biopharma","slug":"biopharma","term_group":0,"term_taxonomy_id":51,"taxonomy":"post_tag","description":"","parent":0,"count":50,"filter":"raw","term_order":"0"},{"term_id":52,"name":"biopharmaceutical","slug":"biopharmaceutical","term_group":0,"term_taxonomy_id":52,"taxonomy":"post_tag","description":"","parent":0,"count":58,"filter":"raw","term_order":"0"},{"term_id":722,"name":"particle analysis","slug":"particle-analysis","term_group":0,"term_taxonomy_id":722,"taxonomy":"post_tag","description":"","parent":0,"count":19,"filter":"raw","term_order":"0"}],"_links":{"self":[{"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/posts\/6666","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/users\/60"}],"replies":[{"embeddable":true,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/comments?post=6666"}],"version-history":[{"count":0,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/posts\/6666\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/media\/6667"}],"wp:attachment":[{"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/media?parent=6666"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/categories?post=6666"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/tags?post=6666"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}